The Utility of Ischemia Modified Albumin (IMA) in Sepsis

NCT ID: NCT00448968

Last Updated: 2007-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-09-30

Brief Summary

The purpose of this study is to determine if levels of ischemia modified albumin (IMA) in blood are elevated in patients with suspected infection and are predictive of severity of illness in patients with sepsis.

In order to compare subjects with infection to those without infection who are representative of the ED population at each site, a group of non-infected control patients will be enrolled. Each hospital will enroll subjects with age (by decade) and sex matched controls to reflect the population of subjects suspected of infection.

Detailed Description

Sepsis is an unconquered challenge in medicine, affecting people of all ages and demographics. Severe sepsis affects approximately 751,000 patients in the United States per annum, with healthcare costs approaching $16.7 billion dollars a year. Mortality from severe sepsis and septic shock approaches 30 - 70 % with 215,000 deaths annually. Thus, sepsis is a disease with healthcare dollars and mortality rates approaching those of heart disease and cancer.

Identifying patients with sepsis, and in particular hypoperfusion, is a challenge to the clinician. A variety of clinical and laboratory findings are helpful, but there is no single test to identify sepsis or assess its severity.

Ischemia and reactive oxygen species play a significant role in the pathogenesis of sepsis. Moreover, there is evidence to suggest that septic shock results in dysfunction of autoregulatory mechanisms and misdistribution of blood flow, precipitating both regional and global ischemia. A method that can help rapidly assess hypoperfusion would be clinically useful. Ischemia modified albumin (IMA) is a potential marker for ischemia in acute coronary syndrome patients; thus, it is hypothesized that IMA may be also useful as a prognostic biomarker for clinical identification of infection and the severity of illness in patients with sepsis.

Conditions

Sepsis; Severe Sepsis; Systemic Inflammatory Response Syndrome; Sepsis Syndrome

Keywords

Sepsis; Ischemia Modified Albumin; Systemic Inflammatory Response Syndrome

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Able to provide informed consent
• Clinical suspicion of infection

• 18 years of age or older
• Emergency Department presentation as a result of a non-infectious etiology as determined by the treating clinicians
• Able to provide informed consent

Exclusion Criteria

• Active chest pain of suspected cardiac origin
• ST elevation myocardial infarction or dynamic ST changes on EKG
• Pregnant women
• Cocaine use
• Liver disease
• Unable to speak or understand the English language

• Suspected Infection
• Temperature >100.4°F
• Pregnant women
• Possible cardiac, intestinal or cerebral ischemia
• Liver disease
• Any source of inflammation as part of their presentation
• cancer, any type

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inverness Medical Innovations

INDUSTRY

Sponsor Role: lead

Principal Investigators

Nathan Shapiro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Munish Goyal, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Rakesh Engineer, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cleveland Clinc

Cleveland, Ohio, United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IMA-0806-003

Identifier Type: -

Identifier Source: org_study_id